New · posted Oct 22
AbbVie · Pharmaceuticals
Lead Quality Dossier Program Auditor
- North Chicago, IL
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The Lead Quality Dossier Program Auditor role supports the Quality Dossier Program audit process by planning and conducting audits required by the Quality Dossier Program. This includes effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process and managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
What you need
What you'll do
- Plan and conduct audits required by the Quality Dossier Program. Audits may be of clinical documents, pre-clinical documents, CMC documents, etc.
- Perform peer reviews of document audits.
- Review audit responses for adequacy, consistency, and compliance
- Maintain the audit schedule
- Represent RD QA for Dossier Program related meetings/activities/functions as needed.
- Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
- Identify and resolve problems through effective interpersonal skills.
- Work independently as well as part of a team
- Maintain effective communication of program related information.
- Bachelor’s degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required.
- 5+ years’ experience in the Medical Device or Pharmaceutical industry,
- Experience in Quality Assurance or Regulatory Affairs (preferred)
- Quality Assurance auditing experience (preferred)
- Planning and conducting audits required by the Quality Dossier Program
- Effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process.
- Coordinating the review and tracking of audit responses and associated tasks across multiple dossier programs.
- Managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
- Escalating potential quality issues to management
- Assist in the management of Due Diligence and Post-Closure Quality Assessment activities in support of projects across one or more aspect of the business.
- Assist in the coordination, review, and tracking of RDQA activities needed to complete Due Diligence and Post-Closure Quality assessments.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$110,000 – $209,000 a year
Employer providedPaid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Long-term incentive programs
Where you'll work
North Chicago, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in North Chicago, IL
From the posting
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 34% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Illinois20 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $110,000 | — | $209,000 |
| Illinois (middle half) | $126,500 | $130,000 | $146,000 |
| All US (middle half) | $102,500 | $119,000 | $137,500 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Collaboration and leadership6
- Regulatory submissions5
- Documentation and SOPs4
Company hiring pulse
AbbVie on Regulatory Jobs
- 51
- Open roles
- 31
- Distinct roles
- 11
- Locations
By discipline
- Regulatory28 55%
- Quality22 43%
- Compliance & Safety1 2%
By level
- Director22 43%
- Manager15 29%
- Senior & Principal9 18%
More roles at AbbVie
- View role
Digital Quality Engineer
Tempe, AZSenior & PrincipalPharmaceuticals$66K–$126K
- View role
QA Specialist (Batch Record Reviewer)
Waltham, MAAssociate & SpecialistPharmaceuticals$59K–$104K
- View role
Quality Senior Manager
Mettawa, ILManagerPharmaceuticals$125K–$237K
- View role
Engineer, Quality
Tempe, AZAssociate & SpecialistPharmaceuticals$66K–$126K
Similar Quality Assurance roles elsewhere
- View role
Quality Performance & Value Lead
TakedaLibertyville, ILSenior & PrincipalPharmaceuticals$154K–$243K
- View role
Quality Specialist III
Thermo Fisher ScientificGreenville, NCSenior & PrincipalPharmaceuticalsSalary not listed
- View role
QA Associate III - Process (3rd Shift)
TolmarFort Collins, COSenior & PrincipalPharmaceuticals$52K–$56K
- View role
Complaint Quality Approver
Johnson & JohnsonGurabo, PRSenior & PrincipalPharmaceuticalsSalary not listed
Lead Quality Dossier Program Auditor at AbbVie
Open until filled. $110K–$209K a year, employer provided.